Type I diabetes (T1DM) is the second most common chronic illness effecting children in the USA. Worldwide, Type I diabetes is increasing in incidence, and its underlying etiology remains elusive. Nevertheless, recent data supports the notion that early and intensive management of Type I diabetes can 1) decrease long-term complications of diabetes; and 2) may significantly improve beta cell function and insulin secretion over ensuing years. To this end, we propose using insulin pump therapy to preserve and/or enhance residual endogenous B-cell secretory capacity among patients with newly diagnosed Type 1 DM. Furthermore, we anticipate that early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple daily injection (MDI) therapy, and will be well-tolerated by the patient. These data will provide important pilot information to explore the potential role of intensive insulin pump therapy in the treatment of children newly diagnosed with Type I diabetes. The specific aim of this study is to test the following hypothesis: Early use of insulin pump therapy is effective in preserving or enhancing residual endogenous pancreatic B-cell secretory capacity among patients with newly diagnosed T1DM: Moreover, early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple injection therapy, and will be well-tolerated by the patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration.
CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.
Arkansas Children's Hospital/Research Institute
Little Rock, Arkansas, United States
Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.
Time frame: 12 months
Changes in Glycemic Control, as Assessed by the Change in Hemoglobin A1c and Variations in Daily Blood Glucose Measurements (Fasting BG and CGMS) From Day 1 of Treatment to Month 12 of Treatment.
Time frame: 12 months
Changes in Daily Insulin Requirements Over Time
Time frame: 12 months
Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.
Time frame: 12 months
Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.
Time frame: 12 months
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